MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOGEN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G179

Device Problems Premature Discharge of Battery (1057); Battery Problem (2885); Impedance Problem (2950)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a routine follow-up appointment, a substantial decrease in the battery longevity was noted from this device.A decrease in the left ventricular (lv) pacing impedance was also observed.Boston scientific technical services were contacted and recommended emergent device replacement to resolve the event.At this time, the device remains implanted and in service.The patient was stable with no adverse consequences.

Event Description

It was reported that during a routine follow-up appointment, a substantial decrease in the battery longevity was noted from this device.A decrease in the left ventricular (lv) pacing impedance was also observed.Boston scientific technical services were contacted and recommended emergent device replacement to resolve the event.The device was explanted and will be returned for analysis.No additional adverse patient effects were reported.

Manufacturer Narrative

Patient code 3191 captures the reportable event of surgery.

Manufacturer Narrative

Patient code 3191 captures the reportable event of surgery.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.However, the battery voltage measurements displayed a pattern of irregular discharge due to programmed parameter changes.Further analysis of diagnostic data demonstrated a depletion pattern that is similar to other devices that depleted normally.The cause of the premature depletion could not be determined as the device operated normally during the analysis.

Event Description

It was reported that during a routine follow-up appointment, a substantial decrease in the battery longevity was noted from this device.A decrease in the left ventricular (lv) pacing impedance was also observed.Boston scientific technical services were contacted and recommended emergent device replacement to resolve the event.The device was explanted and was received for analysis.

• Brand Name: AUTOGEN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 11201249
• MDR Text Key: 227746096
• Report Number: 2124215-2020-28638
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: EZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/17/2017
• Device Model Number: G179
• Device Catalogue Number: G179
• Device Lot Number: 141972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 03/05/2021; 05/11/2022
• Supplement Dates FDA Received: 04/07/2021; 05/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention